Clinical Risk Evaluation Project Manager

Clinical Risk Evaluation Project Manager

We are seeking a Clinical Risk Evaluation Project Manager to join one of our leading healthcare clients.

Position Overview

We are seeking an experienced Clinical Risk Evaluation Project Manager to provide cross-functional support in ensuring clinical safety and residual risk information for medical devices is accurate, consistent, and aligned across product documentation throughout the product lifecycle. This role is critical in supporting compliance with quality management systems and global regulatory requirements.

Key Responsibilities

• Lead and support clinical risk evaluation activities across the product lifecycle.
• Develop and maintain Risk Evaluation Files (REFs), including clinical risks, anticipated adverse events, contraindications, and safety information.
• Facilitate and lead Risk Alignment Committee (RAC) meetings, collaborating with cross-functional teams (Regulatory, Clinical, Medical Affairs, R&D, Quality, Labeling).
• Analyze and interpret clinical safety data from multiple sources, including clinical studies, post-market data, complaints, and scientific literature.
• Ensure consistency of clinical risk information across key documents such as IFUs, CERs, PSURs, SSCPs, and Risk Management Reports.
• Support global regulatory submissions and respond to inquiries from regulatory authorities, ethics committees, and review boards.
• Maintain knowledge of assigned products, therapeutic areas, and applicable regulations.
• Drive continuous improvement initiatives related to clinical risk processes.
• Ensure compliance with applicable regulatory standards (FDA, ISO, EU MDR, and related guidelines).

Required Qualifications

• Bachelor's degree (advanced degree in Medicine, Nursing, or Biomedical Sciences preferred)
• Minimum 5+ years of experience in clinical research, healthcare, medical writing, or related fields within the medical device or pharmaceutical industry
• Strong understanding of clinical research and regulatory guidelines
• Excellent analytical, critical thinking, and problem-solving skills
• Strong written and verbal communication skills, including technical writing
• Ability to manage multiple projects in a fast-paced environment

Preferred Qualifications

• Experience in the medical device industry
• Familiarity with regulatory standards such as ISO 13485, ISO 14155, EU MDR, FDA guidelines
• Experience working in cross-functional, matrixed environments

Key Skills

• Clinical risk evaluation and documentation
• Regulatory compliance and submission support
• Technical and medical writing
• Cross-functional collaboration
• Data analysis and interpretation
• Project management and organization